Significance Testing

Hypothesis testing or Significance testing is the classical way to test the validity of biological assays. While these tests are very robust they tend to fail in very precise assays. The US Pharmacopeia introduced Similarity Testing as an alternative.

Hypothesis Testing

Hypothesis testing or significance testing is a robust way to test the suitability of your bioassays. The tests can be conducted without prerequisites. In contrast to the modern way of equivalence or similarity testing these tests are available without development of margins. They are applied as F-Tests in quantitative response assays or as Chi-Square-Tests for dichotomous assays.

Available Tests in PLA 3.0

Significance of Regression

Significance of Non-Parallelism

Significance of Non-Linearity (Lack of Fit)

Significance of Non-Similarity (for Slope-Ratio model)

Significance of the Slope

Significance of the Square Coefficient

Significance of the Square Coefficient (Assay Level)

Significance of the Difference of Quadratics (legacy test for compatibility with PLA 1.2)